OpenLegislation

Paragraph 4 Extension application

Original text. Later amendments are not shown.

An extension application is an application—

(a)

for an extension of a marketing authorization within the meaning of Article 2(4) of EC Regulation No. 1234/2008; and

(b)

which includes the result of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive.